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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC CATARACT PACK - INST OF OKLA

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MEDLINE INDUSTRIES, INC CATARACT PACK - INST OF OKLA Back to Search Results
Catalog Number VAL024CAIOC
Device Problem Particulates (1451)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that during a cataract procedure, a particulate was injected into the patient's eye. The facility reported that the particulate was found on different components within the cataract pack. The customer stated the patient followed up with a retina doctor, related to the reported incident. According to the customer, the particulate was not noticed upon opening the cataract pack. No additional information is available. The sample was received for evaluation. White pieces of styrofoam from support tray was found on btc of some packs. A root cause for the reported incident could not be determined. Due to the reported incident, and in an abundance of caution, this mdr is being filed. If additional information becomes available, the report will be re-opened and re-evaluated.
 
Event Description
It was reported that during a cataract procedure, a particulate was injected into the patient's eye.
 
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Type of DeviceCATARACT PACK - INST OF OKLA
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC
three lakes drive
northfield, il
Manufacturer Contact
kathy woods
three lakes drive
northfield, il 
9317708
MDR Report Key10150796
MDR Text Key196450981
Report Number1423395-2020-00011
Device Sequence Number1
Product Code OJK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVAL024CAIOC
Device Lot Number20CBR275
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/12/2020 Patient Sequence Number: 1
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